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Recall Observatory FDA recall evidence

Device product

Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7

Z-0492-2014

September 19, 2013

Class II

Product summary

Firm
Aesculap, Inc.
Event
Event 66536
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-0492-2014

Official wording

Reason: The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.

Code information: lots: 51468773, 51447588, 51468302, 51503760, 51571394, 51585136, 51447597

Distribution pattern: Distributed in FL and MD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.